Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
130
Countries
2
Sites
11
Non-Hodgkin Lymphoma
Key facts
- Sponsor
- F. Hoffmann-La Roche AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 23 Apr 2026 → ongoing
- Decision date (initial)
- 2024-08-19
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-505185-28-00
- EudraCT number
- 2021-005745-33
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Non-Hodgkin Lymphoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | HLGT | 10025320 | Lymphomas non-Hodgkin's B-cell | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
F. Hoffmann-La Roche AG
- Sponsor organisation
- F. Hoffmann-La Roche AG
- Address
- Grenzacherstrasse 124
- City
- Basel
- Postcode
- 4058
- Country
- Switzerland
Scientific contact point
- Organisation
- F. Hoffmann-La Roche AG
- Contact name
- Trial Information System - TISL
Public contact point
- Organisation
- F. Hoffmann-La Roche AG
- Contact name
- Trial Information System - TISL
Locations
2 EU/EEA countries · 11 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ongoing, recruiting | 20 | 5 |
| Spain | Ongoing, recruiting | 32 | 6 |
| Rest of world
Israel, United Kingdom, United States
|
— | 78 | — |
Investigational sites
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Hematology Department, Piazzale Spedali Civili 1, 25123, Brescia
Ospedale San Raffaele S.r.l.
Lymphoma Unit - Department of Onco-Hematology, Via Olgettina 60, 20132, Milan
Azienda Ospedaliero Universitaria Pisana
Hematology Department, Via Roma 67, 56126, Pisa
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Hematology Unit, Via Pietro Albertoni 15, 40138, Bologna
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Hematology Department, Via Piero Maroncelli 40, 47014, Meldola
Hospital Universitario De Salamanca
Oncology, Paseo De San Vicente 58-182, 37007, Salamanca
Clinica Universidad De Navarra
Oncology, Calle Marquesado De Santa Marta 1, 28027, Madrid
Hospital Universitario Y Politecnico La Fe
Oncology, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Hospital General Universitario Gregorio Maranon
Oncology, Calle Del Doctor Esquerdo 46, 28009, Madrid
Institut Catala D'oncologia
Oncology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Universitari Vall D Hebron
Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Italy | 2026-04-23 | 2026-04-23 | |||
| Spain | 2026-04-23 | 2026-04-23 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-03 | Spain | Acceptable with conditions 2024-07-24
|
2024-07-24 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-11-22 | Spain | Acceptable 2025-02-04
|
2025-02-11 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-05-27 | Spain | Acceptable 2025-07-17
|
2025-07-18 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-09-25 | Spain | Acceptable 2025-11-04
|
2025-11-10 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2026-01-30 | Spain | Acceptable 2026-03-12
|
2026-03-16 |